Hexima Ltd · ASX:HXL
Hexima — Corporate Update (June 2017)
25 slides from Hexima's corporate update, June 2017
Slide 1: Shareholder Update Q1 2017
Shareholder Update Q1 2017
Slide 2: Forward looking statements
Forward looking statements Certain statements in this presentation relate to the future, including forward looking statements relating to Hexima’s future expectations, beliefs, goals, plans, prospects, financial position and strategy. These forward looking statements involve known and unknown risks,
Slide 3: HXP124
HXP124 Hexima is developing a novel therapeutic (HXP124) for the treatment of fungal nail infections (onychomycosis). HXP124 has the potential to be superior to current therapies. • Potent, broad-spectrum antifungal molecule —Member of the Plant Defensin class of molecules • Readily penetrates nai
Slide 4: Recent progress
Recent progress Pre-clinical animal toxicology studies are complete and preparation is underway for clinical trials. CY 2017 CY 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre-clinical animal toxicology studies Complete Phase I/IIa human clinical safety and efficacy studies United States Food and Drug Administrat
Slide 5: Recent progress - HXP124 was not toxic in a dermal irritation minipig study
Recent progress - HXP124 was not toxic in a dermal irritation minipig study 42-day GLP repeat-dose dermal toxicity study in minipigs • No Observable Adverse Effect Level (NOAEL) of 50 mg/kg (highest dose) • Very low absorption through the skin • No systemic toxicity effects at the highest dose (50
Slide 6: Global onychomycosis market
Global onychomycosis market US$3.06 billion in 2015 and projected to reach US$4.7 billion by 2021. Major deficiencies in current therapies. • Poor efficacy rates • Long treatment times • Oral therapies can be toxic • Expensive —Estimated that between 50 and 90% of individuals with fungal nail infe
Slide 7: Global onychomycosis products
Global onychomycosis products Approved Topical Therapies for Onychomycosis Loceryl® Penlac®/Rejuvenail® KERYDIN® Jublia® (5% Amorolfine) (8% Ciclopirox) (5% Tavaborole) (10% Efinaconazole) 48 week treatment 48 week treatment 48 week treatment 48 week treatment 1-2% complete cure rate 5-9% complete c
Slide 8: HXP124: a broad-spectrum antifungal defensin
HXP124: a broad-spectrum antifungal defensin Kills several human fungal pathogens including the yeast Candida and the agents responsible for fungal nail infections. Very specific for fungal cells. • Not active against mammalian cells • Not active against bacteria No treatment Low dose High dose (1
Slide 9: HXP124 kills fungi more readily than current treatments for nail infections
HXP124 kills fungi more readily than current treatments for nail infections 100% 90% 80% Kills fungal cells within 30 min. 70% Percent living cells • Inefficient killing by drugs currently 60% on the market means the fungus is 50% likely to become resistant during 40% long treatment times and may 3
Slide 10: Fungi do not readily develop resistance to HXP124
Fungi do not readily develop resistance to HXP124 We cultured C. albicans in the presence of HXP124 and efinaconazole to examine how quickly resistance could develop. C. albicans did not become resistant to HXP124 after 15 rounds of selection. • HXP124 has very high kappa (steepness of killing c
Slide 11: HXP124 is likely to penetrate nails faster and more efficiently than current products
HXP124 is likely to penetrate nails faster and more efficiently than current products Topical treatments for fungal nail disease must penetrate human nails to reach the site of infection. An in vitro nail adapter assay can be used to assess nail penetration. nail adapter cadaver nail or nail clipp
Slide 12: HXP124 accumulates in the nail plate
HXP124 accumulates in the nail plate HXP124 accumulates in the nail at the site of application and diffuses sideways to areas that were not dosed. HXP124 within the nail plate 15 Amount of HXP124 in drill site 10 (µg) 5 Dose site 0 Dose Site Peripheral edge Nails dosed with HXP124 in nail penetrati
Slide 13: HXP124 is as effective as Jublia in an infected nail model
HXP124 is as effective as Jublia in ® an infected nail model MedPharm (UK) have tested HXP124 2. HXP124 applied topically in an “infected nail model” to provide additional confidence that HXP124 passes through nails and kills fungal nail adapter cells. human nail • Industry standard assay. 1. funga
Slide 14: HXP124 is as effective as Jublia in an infected nail model
HXP124 is as effective as Jublia in ® an infected nail model HXP124 killed over 95% of fungal cells within 7 days and was as efficient as Jublia® in this model. 40% (% relative to infected control) 2. HXP124 applied topically ATP levels* 30% nail adapter human nail 20% 1. fungal infection developed
Slide 15: HXP124 can be produced rapidly and economically in Australia
HXP124 can be produced rapidly and economically in Australia Produced in off-patent yeast system. Two-step purification process. • Highly pure protein (>99.99%) GMP* manufacture completed by LuinaBio under contract. HXP124 is stable in formulation for >4 weeks at 40 degrees Celsius. • No loss of
Slide 16: HXP124 has a good safety profile in initial preclinical toxicology studies
HXP124 has a good safety profile in initial preclinical toxicology studies Bovine corneal opacity and permeability study (assess potential eye irritation in case of accidental exposure) • No increase in opacity or permeability of isolated corneas • HXP124 classified as ‘No Category’ (poses minimal
Slide 17: HXP124 was not toxic in a dermal irritation minipig study
HXP124 was not toxic in a dermal irritation minipig study 42-day GLP repeat-dose dermal toxicity study in minipigs • No Observable Adverse Effect Level (NOAEL) of 50 mg/kg (highest dose) • Very low absorption through the skin • No systemic toxicity effects at the highest dose (50 mg/kg) • Very slig
Slide 18: HXP124 development timetable
HXP124 development timetable CY 2017 CY 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre-clinical animal toxicology studies Complete Phase I/IIa human clinical safety and efficacy studies United States Food and Drug Administration Investigational New Drug (IND) application Business Development Proof of concept stud
Slide 19: HXP124 commercialisation plan
HXP124 commercialisation plan Proof-of-concept efficacy data is a significant value creation step during drug development. If positive clinical efficacy data is obtained, Hexima intends to licence HXP124 to a pharmaceutical companie(s) to generate upfront and future milestone payments and licensin
Slide 20: Licencing HXP124 in Japan
Licencing HXP124 in Japan Hexima intends to seek to licence HXP124 for the Japan market in 2017, prior to obtaining results from phase I/IIa clinical trials. • Hexima believes that the large, proven Japanese market for onychomycosis makes it a key target market for HXP124. • Hexima believes that a
Slide 21: Hexima's defensin platform is applicable to other fungal diseases
Hexima’s defensin platform is applicable to other fungal diseases Vulvovaginal candidiasis (thrush) • HXP124 and other Hexima lead candidates rapidly kill Candida spp • HXP124 is stabile in a topical formulation which is a significant advantage for this application • Pursuant with our strategy to p
Slide 22: Summary
Summary Hexima has developed a defensin platform applicable to a range of applications. Hexima is developing HXP124 as a superior therapeutic for onychomycosis. • Better nail penetration. • Rapidly kills fungal cells. • Anticipating shorter treatment regimen. —4 weeks vs 48 weeks. Hexima expects
Slide 23: Financial position
Financial position Balance Sheet (as at 31 May 2017) Please note: these are unaudited figures. CURRENT ASSETS Cash and cash equivalents $4,622,927 Rights issue to raise ~$4 million Receivables TOTAL CURRENT ASSETS $1,364,879 $5,987,806 completed in March. NON-CURRENT ASSETS Investments $22 Plant an
Slide 24: Share trading
Share trading Some shareholders have indicated that they wish to buy or sell Hexima Shares. Hexima has been contacted by two shareholders, including an entity controlled by G.F. Dan O’Brien, willing to purchase Hexima shares at a price of $0.08. Hexima has appointed Bell Potter to co-ordinate a s
Slide 25: Contacts
Contacts Dr Nicole van der Weerden (CEO) n.vanderweerden@hexima.com.au Ms Elisha Larkin elisha.larkin@hexima.com.au 25